Transjugular intrahepatic portosystemic shunt device

ABSTRACT

An apparatus method for establishing a Transjugular Intrahepatic Portosystemic Shunt between the portal vein from a hepatic vein. The apparatus comprises an elongated hollow outer guide; an outer handle having an inner lumen and a first luer lock, the outer handle attached at a proximal end of the outer guide, the outer guide in flow communication with the inner lumen and the first luer lock; an elongated hollow inner needle; and a hub having a second luer lock, the hub attached at a proximal end of the inner needle, the inner needle in flow communication with the second luer lock. The inner needle is slidingly received into the outer guide through the inner lumen. The inner needle rotates within the outer guide by manipulation of the hub; and a distal tip of the inner needle is deployed out of and beyond a distal tip of the outer guide.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/651,682 filed Oct. 15, 2012, which is a continuation-in-partof U.S. patent application Ser. No. 12/644,452 filed Dec. 22, 2009, nowU.S. Pat. No. 8,287,481, which claims the benefit of priority to expiredU.S. Provisional Patent Application No. 61/140,693 filed Dec. 24, 2008.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an apparatus and method for quicklylocating a liver portal vein to establish a shunt through a human liverbetween the portal vein and the hepatic vein, and more particularly to aTransjugular Intrahepatic Portosystemic Shunt (“TIPS”) device and amethod for establishing a TIPS using the device.

2. Description of Related Art

The human liver has many functions essential to life including breakingdown fats, glucose metabolism/storage, urea production, amino acidsynthesis, toxin filtration, storage of vitamins and minerals, andcholesterol metabolism. On average, the healthy liver receives around70-75% of its blood supply from the portal vein and 25-30% from thehepatic artery. Blood leaves the liver through the hepatic veins whichcommunicate with the inferior vena cava just below the heart.

Liver cirrhosis is a term that refers to irreparable damage to the liverwhere the hepatic parenchyma is progressively replaced with scar tissue.With time, this can progress to complete liver failure. There arenumerous causes of liver cirrhosis, but common causes include alcoholabuse, hepatitis, non-alcoholic steatohepatitis (NASH), toxin/drugexposure, and various inherited and autoimmune conditions. As the liverbecomes cirrhotic, the normal blood flow patterns become altered.Specifically, the pressure within the portal veins increases causing theblood that would normally flow to the liver to “back-up.” Over time theportal blood that normally flows towards the liver (hepatopedal) canreverse and flow away from the liver (hepatofugal). As the portal veinpressures rise, the blood finds alternative routes to return to theheart. This typically occurs in the form of variceal vessels that areparticularly prone to hemorrhage with potentially fatal consequences.

In addition, the increased portal vein pressures observed with cirrhosisraises capillary hydrostatic pressures within the splanchnic vascularbed of the viscera. Coupled with impaired renal function and sodiumretention, as the hydrostatic pressure rises, a transudative fluidcollection, known as ascites, can form in the patient's abdomen.Although typically this is initially managed with medical therapy, theamount of fluid can become quite large and refractory to medicaltherapy.

Originally described by Rosch et al. in 1969, the TIPS procedure createsa shunt between the portal veins and the hepatic veins allowing blood tobypass the cirrhotic hepatic parenchyma that is responsible for theelevated portal vein pressures. In so doing, the TIPS proceduredecreases portal pressure and is indicated in the management of varicealbleeding refractory to medical therapy, refractory ascites, andrefractory hepatic hydrothorax (fluid surrounding the lungs secondary toliver failure).

There are several commercially available kits for the TIPS procedure.The TIPS procedure is performed under general anesthesia by accessingthe patient's right internal jugular vein and advancing a catheterthrough the superior vena cava, heart, and inferior vena cava to theright hepatic vein. Once catheter access to the right hepatic vein ismade, a larger sheath is then placed into the right hepatic vein.Through this sheath a large needle (typically 16 Gauge) is pushedthrough the wall of the hepatic vein into the parenchymaanteroinferomedially in the expected direction of the right portal vein.After the needle has been advanced, a syringe is attached to the back ofthe needle and the needle is slowly withdrawn. When blood is aspirated,a small injection of contrast is made into the needle to confirm accessinto the right portal vein. Wire access through the needle into theright portal vein and main portal vein is then made. Over this wire, atract is balloon dilated and a covered stent is placed thus forming theshunt.

Despite the use of preprocedural imaging as well as intraproceduralwedge portography, access to the portal vein can often prove difficultrequiring numerous passes of the needle before access is obtained. Thepassage of the needle through the liver is associated with complicationsincluding intraperitoneal bleeding (frequency 1-13%), hemobilia(frequency 1-4%), and fistula formation (frequency <1%). Equallyimportant, the difficulty of portal vein access extends procedure timewith the increased use of hospital resources/expenses and the added riskto the patient of prolonged anesthesia and fluoroscopic radiationexposure. Therefore, there is a need for a TIPS device and method thatcan obtain access to the portal vein more safely and rapidly.

SUMMARY OF THE INVENTION

The present invention relates to a device that is designed to improvethe safety and efficacy of catheterization of the portal vein during aTIPS procedure and a method for using the device. This is accomplishedby simultaneously advancing multiple smaller needles through the liverparenchyma from the distal end of the TIPS needle of the device. In sodoing, the device allows sampling from a significantly larger volume ofthe liver with each pass thereby facilitating the rapid catheterizationof the portal vein from the hepatic vein.

The proposed device is superior to the prior art because it employs aplurality of needles, each smaller than the needle used in a typicalTIPS procedure, that are simultaneously advanced into the hepaticparenchyma. The needles will spread apart in area progressively as theyare manually advanced into the hepatic parenchyma with the tips forminga square or polygonal pattern accordingly. The use of multiple needlesmultiplies the likelihood of catheterizing the portal vasculature andreduces the time in which this is done compared to passage of a singleneedle as is typically employed in a TIPS procedure.

In addition, the needles used in this device are considerably smallerthan the 16 Gauge needle used in a typical TIPS procedure. The presentinvention uses needles as small as 21 or 23 Gauge. The use of smallerneedles is less traumatic to the vascular liver. It therefore willdecrease the likelihood of potentially fatal complications, includinghemorrhage, hemobilia, fistula creation, and injury to adjacent organs.The larger needle that houses these smaller needles will only beadvanced a very short distance into the hepatic parenchyma and thereforeis much less invasive.

An additional embodiment of the invention includes an insertionapparatus comprising an outer guide with either a straight (discussed inthe next paragraph) or steerable inner needle. The assembled apparatuswith the steerable needle allows the needle to be directed in the samedirection as the outer guide. The steerable needle can be directed inany direction along a 360 degree arc. The employment of a steerableinner needle enhances the ease of portal vein catheterization byallowing the operator to steer the needle in the expected direction ofthe portal vein. This confers the same advantages of the multi-needleembodiment, including decreased procedure time and enhanced safety. Thereduced procedure time confers advantages of cost-savings, decreasedanesthesia risk to the patient, and decreased radiation exposure to boththe patient and the operator. A further embodiment of this apparatusincludes the substitution of the curved inner needle (which allowssteering) for a straight inner needle (non-steerable). This would beused in the event that the operator believes the portal vein liesdirectly in front of the curved outer guide. In such a situation astraight needle would be optimal for portal vein catheterization as itprovides a more direct route.

In some embodiments, this apparatus comprises an elongated hollow outerguide; an outer handle having an inner lumen and a first luer lock, theouter handle attached at a proximal end of the outer guide, the outerguide in flow communication with the inner lumen and the luer lock; anelongated hollow inner needle; and a hub having a second luer lock, thehub attached at a proximal end of the inner needle, the inner needle inflow communication with the second luer lock. The inner needle isslidingly received through the first luer lock and into the outer guidethrough the inner lumen. The inner needle is configured to rotate withinthe outer guide by manipulation of the hub; and a distal tip of theinner needle is deployed out of and beyond a distal tip of the outerguide, the distal tip of the inner needle configured to be advanced intothe parenchyma of the liver to locate the portal vein. To assist inlocated the portal vein, the inner needle is capable of aspirating fluidtherethrough.

The present invention also comprising a method of locating a liverportal vein necessary for performing a transjugular intrahepaticportosystemic shunt procedure utilizing the outer guide/inner needledevice, comprising catheterizing, through the jugular vein, a liverhepatic vein of a patient receiving the transjugular intrahepaticportosystemic shunt. Inserting the device into the jugular vein andthrough to the liver hepatic vein. Rotating the outer handle of thedevice until the outer guide is in the expected direction of the liverportal vein. Stabilizing the outer handle and rotating the inner needleby way of the hub in the expected direction of the liver portal vein.Applying pressure to the hub and advancing the distal tip of the innerneedle into the parenchyma of the liver, through the wall of the hepaticvein in a direction towards the portal vein. Creating an aspiratingforce inside the inner needle to locate the liver portal vein andestablishing a shunt to the portal vein.

Consequently, the devices described herein will result in considerablecost savings and improved safety by shortening the length of time of theprocedure. The decrease in procedural time is significant as it lowersthe rate of complications related to the administration of generalanesthesia. Moreover, the decrease in procedural time offers costsavings benefits to the healthcare system.

In another embodiment, the device employs 6 smaller needles that extendfrom the distal end of a TIPS needle.

In yet another embodiment, the device employs 8 smaller needles thatextend from the distal end of a TIPS needle.

In yet still another embodiment, the device employs only one sheath inwhich the TIPS needle passes through.

In yet still another embodiment, the device employs an outer guidereceiving a steerable curved inner needle and an apparatus for themanipulation of the inner needle to locate the portal vein during a TIPSprocedure.

It is an object of the present invention to provide a multi-needled TIPSdevice that can obtain access to the portal vein from the hepatic veinmore safely and rapidly.

It is another object of the present invention to provide a method forusing the multi-needled TIPS device to reduce the time necessary toestablish a shunt.

In accordance with these and other objects which will become apparenthereinafter, the instant invention will now be described with particularreference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a drawing to illustrate a human liver, the hepatic vein, andthe portal vein.

FIG. 2 is a side cross-sectional view in elevation of the presentinvention in a retracted state.

FIG. 3 is a side cross-sectional view in elevation of the presentinvention in an extended state.

FIG. 4 is a side elevational view partially cut away of an outer sheathbuilt in accordance with the present invention.

FIG. 5 is a side elevational view partially cut away of an inner sheathbuilt in accordance with the present invention.

FIG. 6 is a side elevational view of a TIPS needle in a retracted statebuilt in accordance with the present invention.

FIG. 7 is a side view of a TIPS needle with four engaging needles in anextended state and the tip of the TIPS needle in phantom built inaccordance with the present invention.

FIG. 8 is a perspective view partially cutaway of the distal end of aTIPS needle built in accordance with the present invention.

FIG. 9 is a side elevational view of the distal end of a TIPS needlewith a needle stylets in partial phantom built in accordance with thepresent invention.

FIG. 10 is a side elevational view of engaging needles and a commonneedle hub built in accordance with the present invention.

FIG. 11 is a side elevational view of stylets and a common stylet hubbuilt in accordance with the present invention.

FIG. 12 is a side elevational view in cross section of an aspiratingsyringe built in accordance with the present invention.

FIG. 13 is a perspective elevational view of another embodiment of thepresent invention, in a retracted state.

FIG. 14 is a perspective elevational view of another embodiment of thepresent invention, in an extended state also showing the hub cab removedfrom the hub.

FIG. 15 is a close-up perspective elevational view of another embodimentof the present invention.

FIG. 16 is a perspective elevational view of the outer guide used in oneembodiment of the present invention.

FIG. 17 is a perspective elevational view of the inner needle used inone embodiment of present invention.

FIG. 18 is a perspective elevational view of the inner needle hub usedin one embodiment of the present invention.

FIG. 19 is a perspective elevational view of the hub cap used in oneembodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

A multi-needle TIPS device and a method for using the multi-needle TIPSdevice, in accordance with the present invention, are described withinitial reference to FIG. 1. The device and method described herein isdesirable for locating quickly the proper portal vein for establishing ashunt 103 through a human liver 100, connecting the right hepatic vein101 to the right portal vein 102.

Referring now to FIGS. 2, 3, 4, 5, 6, and 7, the device 200 and itsprimary components are depicted in isolation and in a retracted andextended state. FIG. 2 shows the device 200 in the retracted state,which is a non-engaging, default state. An outer sheath 201 is theprimary exterior component of the device 200. The outer sheath comeswith an inner dilator to allow introduction over a wire into the righthepatic vein. The outer sheath 201 is a ten (10) French (for reference,1 French=3 mm) sheath which is made of a semi-rigid material. In FIG. 4,the outer sheath 201 has a shaft that measures between 35 and 40 cm inlength and an outer hub 203 with an outer side port 202 at its proximalend that is designed to allow flushing of the outer sheath 201.

In FIG. 5, the lumen of the outer sheath 201 accommodates an innersheath 204. The inner sheath 204 is an eight (8) French sheath which ismade of a semi-rigid material. The shaft of the inner sheath measures 45cm in length has a tapered end 207. The inner sheath 204 also has aninner hub 205 and inner side port 206 at its proximal end to allow forflushing of the inner sheath 204. The shaft of the inner sheath 204 alsohas a braided metallic wall to allow passage of an 8 French needlewithout damage to the inner sheath 204.

The lumen of the inner sheath 204 accommodates a TIPS needle 208, whichin total measures 50 cm in length, including a curved portion 211 of 7cm at the TIPS needle's distal end 214. The TIPS needle is an eight (8)French needle made of a semi-rigid material. The curved portion 211 hasa 30 degree curve. At distal end of the TIPS needle 208 is a TIPS needletip 209 (See FIG. 6). Near the distal end of the TIPS needle 208, beforethe TIPS needle tip 209, there are four needle holes 212 designed toallow smaller needles to pass through. The TIPS needle also has a TIPSneedle hub 213 at the proximal end 215 of the TIPS needle.

Referring back to FIG. 3 shows the device 200 depicted in the extendedstate. The extended state is the engaging state and is defined by theextension of four (4) engaging needles 216 from the distal end 214 ofthe TIPS needle 204. The engaging needles 216 are each twenty-three (23)gauge needles made from a semi-rigid material and each has a preformedgentle curve in its tip. The engaging needles 216 pass through the TIPSneedle lumen 210, with each engaging needle 216 extending from one ofthe four needle holes 212 of the TIPS needle 208. Inside the TIPS needlelumen 210, the engaging needles 216 are separated by thin horizontal andvertical septations 218 in the TIPS needle lumen 208. As seen in FIG. 7,while extending, the engaging needles 216 progressively spread apart ina square pattern. When fully extended, the engaging needles 216 lie in asquare pattern with 2-3 cm between the needles.

Referring now to FIGS. 8, 9, 10, and 11, the primary components thatcomprise the interior of the device are shown. FIG. 8 shows the proximalend 215 of the TIPS needle 208. At the proximal end 215 of the TIPSneedle 208 is the TIPS needle hub 213. The TIPS needle hub 213 serves asthe base of the TIPS needle 208 and houses the hub adapter 217. As aresult of the horizontal and vertical sepations 218 in the TIPS needlelumen 208, the TIPS needle lumen 208 contains four distinct chambers,each of which can accommodate one engaging needle 216. The engagingneedles are each attached to a common needle hub 223, which allows theengaging needles to be advanced and retracted together. To assure thatproper pattern of the engaging needles 216 when they are extended fromthe TIPS needle 208, each engaging needle 216 has a specific targetchamber within the TIPS needle 208. If the engaging needles 216 areinserted into the proper chamber, then once the engaging needles 216 arecompletely advanced into the TIPS needle 208, the common needle hub 223will engage the hub adapter 217.

Stylets 221, are used to fill the engaging needle lumen 219 and provideadditional rigidity to the engaging needles 216 when they are advancedinto the engaging needle lumen 219. The stylets 221 are of twenty-three23 gauge size, made from a semi-rigid material, and are all attached toa common stylet hub 222. In addition, the stylets 221 have the samepreformed curve as the engaging needles 216. The stylets 221 areutilized by insertion first through a sliding cover 220, then throughthe common needle hub 223, and finally through the engaging needle lumen219.

Referring now to FIG. 12, a specially designed syringe 224 is shown. Thesyringe 224 is a sixty (60) cc syringe that is designed to engage thecommon needle hub 223 (FIG. 9) and provide aspiration through theengaging needle lumen 219. The syringe has an engaging tip 225 with fourindependent syringe chambers 227, where each chamber 227 corresponds toone of the four engaging needle lumen 219 (FIG. 8). Along with anopening for each syringe chamber 227, the engaging tip 225 also houses asyringe adapter 228 that fits the common needle hub 223. When syringe224 is engaged to the common needle hub 223 and the plunger 226 of thesyringe 224 is pulled, aspiration is provided through each of theengaging needle lumen 219.

The operation of the device begins with the access of the right hepaticvein 101 (FIG. 1) from the right jugular vein. Under ultrasoundguidance, a twenty-one (21) Gauge needle will be used to access theright jugular vein. After obtaining access, a 0.018″ wire is advancedthrough the lumen of the twenty-one (21) Gauge needle and its positionconfirmed in the superior vena cava with fluoroscopy. A transitionaldilator is used to upsize the wire. Catheterization of the right hepaticvein 101 is then performed. Wedge hepatic pressures and portography areperformed as needed. The outer sheath 201 and inner dilator are advancedover the wire into the right hepatic vein 101. The inner dilator is thenremoved and the outer side port 202 is connected to a heparinized salineflush.

Next, the TIPS needle 208 is partially inserted into the inner hub 205and then the inner sheath 204, so as not to extend the TIPS needle tip209 beyond the distal end of the inner sheath 204. The assembledapparatus of the TIPS needle 208 and the inner sheath 204 is theninserted into the outer hub 203 and then the outer sheath 201 andextended to the wall of the right hepatic vein 101. Once placed, theinner side port 206 can be connected to a heparinized saline flush asneeded.

The engaging needles 216 with their stylets 221 seated are then advancedinto the TIPS needle hub 213, but the tips of the engaging needles 216are not extended through the holes near the end of the TIPS needle 208.At this point, the assembled device will be as shown in FIG. 2. Next,the TIPS needle 208 is slowly advanced a short distance into the hepaticparenchyma anteromedially in the expected direction of the right portalvein 102. The distance that the TIPS needle is advanced into the hepaticparenchyma will likely be around 1 cm, unlike the usual distance ofapproximately 5 cm that is employed with a typical TIPS apparatus.

Once the TIPS needle 208 is seated in proper position, the engagingneedles 216 with their inner stylets 221 are slowly advanced into thehepatic parenchyma. At this point, the assembled device will be as shownin FIG. 3. The engaging needles 216 are advanced approximately 3-6 cm.As the engaging needles 216 are advanced through the needle holes 212near the end of the TIPS needle 208 into the hepatic parenchyma theywill gradually spread apart in a square shape, as depicted in FIG. 7.When fully extended, the tips of the engaging needles will lie in asquare pattern with 2-3 cm between the needles. Since the needlesprogressively spread with further advancement, extending the engagingneedles 216 a shorter distance will result in the needle tips lyingcloser to one another in a smaller square pattern.

The stylets 221 are removed from the engaging needle lumen 219 bypulling on the common stylet hub 222. As the stylets 221 are withdrawnfrom the engaging needles 216, their tips are covered by the needlecover 220. This needle cover 220 is designed to prevent a needle injuryto the operator and to keep the stylet tips together when disengagedfrom the engaging needles 216. The stylets 221 with their tips coveredby the needle cover 220 can then be placed to the side.

With the stylets removed, the syringe 224 is then attached to the commonneedle hub 223 with each syringe chamber 227 corresponding to oneengaging needle lumen 219. The operator then pulls on the plunger 226 tocause an aspirating force through the engaging needle lumen 219 and thetips of the engaging needles 216. The engaging needles 219 are thenslowly retracted through the hepatic parenchyma while being aspiratedwith the syringe 224 by pulling on the syringe 224 together with thecommon needle hub 223. As the operator retracts the engaging needles216, the individual syringe chambers 227 are carefully inspected for thepresence of portal blood. If blood is not aspirated, the engagingneedles 216 can be withdrawn into the TIPS needle 208 and the stylets221 are replaced into the engaging needle 216. The engaging needles 216are then advanced in a different direction and the process is repeateduntil aspiration of blood is successful.

When blood is aspirated into one of these syringe chambers 227,retraction of the engaging needles 216 is immediately stopped. Thesyringe chamber 227 and corresponding engaging needle lumen 219containing blood are noted. The syringe 224 is then removed from thecommon needle hub 223. A small injection of contrast is then made intothe engaging needle lumen 219 from which blood was aspirated. This isperformed under fluoroscopy to confirm access into the right portal vein102. Next, under fluoroscopy, a 0.018″ wire is advanced into theappropriate engaging needle lumen 219 that had aspirated blood. Thiswire is advanced well into the right portal vein 102 and then into themain portal vein, splenic vein, or superior mesenteric vein as isnecessary to obtain adequate purchase for further intervention.

Once adequate purchase is obtained, the TIPS needle 208 and the attachedengaging needles 216 are pulled back as a unit together over the wire.Serial dilatation is then performed over the 0.018″ wire and the 0.018″wire is upsized for a larger 0.035″ wire. Over the 0.035″ wire balloonangioplasty and placement of a covered stent can be performed as is donewith a typical TIPS procedure. The procedure is completed with a repeatportogram and measurement of portal pressures as well as potentialembolization of varices as required.

With reference to FIGS. 13-19, shown is another embodiment of thepresent invention providing another suitable and improved means oflocating and accessing the portal vein as part of a TIPS procedure.

The assembled apparatus shown in FIG. 13 depicts one embodiment of thepresent invention in an assembled state. An outer handle A (shown alonein FIG. 15) is connected to the outer guide K (shown alone in FIG. 16).The outer handle A has finger grips B along its inferior edge. Thesegrips B allow the operator to torque the outer guide K as desired withone hand (typically the left hand). The outer handle A also has fingerwinglets C. The winglets are used by the opposite hand (typically theright hand) to assist in the deployment of the inner needle J byproviding leverage from which the base of the hand can be pushed againstthe inner needle hub F. The proximal end of the outer guide K has a luerlock D, which not only allows insertion of the inner needle J into theouter guide K, but also allows attachment of a standard syringe theretofor aspiration or injection as needed. The inner lumen E is disposedwithin the outer handle A and extends therethrough in communication withthe outer guide K and luer lock D. In some embodiments, the inner lumenE is just large enough to accommodate passage of a 4 French catheter.The lumen E of the outer handle is in continuity and flow communicationwith the outer guide K and the luer lock D. In some embodiments, theouter guide K, will measure between 40 and 50 cm and will have a gentlecurve at its distal end producing an arc between 20 and 45 degrees. Insome embodiments, the end of the outer guide K is flush with no bevel.

The inner needle J is slidingly and removably received in the outerguide, provided through luer lock D, through lumen E and into the outerguide K. At the proximal end of inner needle J is hub F. The hub F has ahub cap G which covers a luer lock I which provides a passage betweenthe hub F and the inner lumen of the inner needle J. This luer lock willsimilarly allow not only passage of a 0.035 inch wire through the hub Fand into the inner needle J, but also will allow attachment of astandard syringe for aspiration or injection as needed. The inner needlehub F and the hub cap G are depicted in isolation in FIGS. 18 and 19respectively, with luer lock I shown in FIG. 18, protruding from the hubF.

The inner needle hub F allows the operator to turn and torque the innerneedle J in a 360 degree radius within the outer guide K. This isperformed in a 1:1 fashion as the hub F is fixed to the proximal end ofthe inner needle J. The inner needle hub F has a marker H, whichdelineates the direction of the curve of the inner needle J so that theoperator understands the direction the inner needle J is pointing. Thisallows the user to manually determine the orientation of the distal tipof the inner needle J without having to rely on imaging such asfluoroscopy.

In some embodiments, the inner needle J will measure between 45 and 55cm in length and will have a gentle curve at its distal end producing anarc between 20 and 45 degrees. Accordingly, the distal end of the innerneedle J will substantially match the curvature and profile of thedistal end of the outer guide K. A straight version of the inner needleJ with the same length is an alternative embodiment of the presentdevice. Both the straight and curved versions of the inner needle J willhave a beveled tip to provide the necessary sharpness to penetrate theparenchyma of the liver. This is dissimilar from the non-beveled distaltip embodiment of the outer guide K, since the outer guide K would notneed to be used to penetrate the liver.

In some embodiments, the inner needle J has a hydrophilic coating orTeflon coating to reduce the friction between the inner needle J and theouter guide K. As an alternative embodiment of the device, the innerneedle may have a 4 French plastic polymer sleeve/catheter around theoutside of the inner needle J. Such a sleeve/catheter will have a luerlock at the end (allowing it to lock to the inner needle hub F), andwill closely resemble a standard diagnostic angiographic catheter. Thesleeve/catheter will advance with the inner needle J during use of thedevice. The purpose of the sleeve/catheter is to reduce friction as wellas facilitate catheterization of the portal vein and advancement of thewire once the portal vein is found with the inner needle J.

The operation of this embodiment of the present invention is as follows:As with any standard TIPS procedure, the goal is to create a shuntbetween the hepatic vein and portal vein using a covered stent as aconduit for blood flow through the liver. This is demonstrated in FIG. 1where blood flows from the portal vein, 102, to the hepatic vein, 101.Typically this involves communication between the right hepatic vein andthe right portal vein, but variations on this exist depending upon thepatient's anatomy and the need for additional shunting.

Using standard angiographic technique, catheterization of the rightjugular vein, the inferior vena cava, and then hepatic vein (typicallyright) is obtained. After confirming appropriate hepatic veincatheterization, a stiff wire is placed distally within the vein. Overthe stiff wire, a 10 French sheath is advanced well into the hepaticvein. At this point, wedged portal pressures and wedged portography withan occlusion balloon can be performed at the operator's discretion todelineate the location of the target portal vein and assess the degreeof portal hypertension.

The apparatus of the present invention is then inserted through thesheath and is advanced to the tip of the sheath. The assembled apparatusis advanced such that the inner needle J and hub F are retracted so thatthe sharp tip of the inner needle J initially does not extend beyond thetip of the outer guide K. Once the distal tip of the assembled apparatusreaches the tip of the sheath, the sheath is gently withdrawn to exposethe outer guide K.

Using the outer handle A the apparatus is rotated in the generalexpected direction of the target portal vein. The operator thenstabilizes the outer handle A and therefore outer guide K, with his orher left hand. The inner needle hub F is then rotated with theoperator's right hand in the expected direction of the target portalvein to fine tune the targeting of the portal vein. Using the righthand, two fingers are placed on the finger winglets C. The base of theright hand is then used to apply pressure to the base of the innerneedle hub F, advancing the distal tip of the inner needle J into theliver parenchyma.

The hub cap G of the inner needle hub F is then removed, exposing theluer lock I of the needle hub F. A saline containing syringe is attachedto luer lock I and a small amount is injected to clear the lumen of theinner needle J. The saline syringe is removed, and a contrast dyesyringe is attached. A combination of gentle aspiration and short puffsof contrast dye are made while the inner needle J and inner needle hub Fare slowly retracted back towards the outer guide K. Once the portalvein is found, a wire can be directly advanced through the lumen of theinner needle J into the portal vein or alternatively, thesleeve/catheter of the inner needle J can be advanced over the innerneedle, J into the portal vein at which time the inner needle J andinner needle hub F can be removed. If the portal vein is not found oninitial deployment of the inner needle J the hub cap G can be replaced,and then the inner needle J and inner needle hub F can be rotated to anew orientation and the process repeated until the portal vein is found.

Regardless of the exact technique, once a wire is successfully advancedinto the portal vasculature, the remainder of the TIPS procedure iscompleted with standard technique. This requires advancement of a 4French catheter over a wire and through the outer guide handle A, andouter guide K, into the portal vein. The initial wire advanced is thenexchanged for a stiffer wire over which a diagnostic 4 French flushcatheter can be advanced and used to perform portography and obtainportal pressures. The stiff wire is replaced and the diagnostic flushcatheter removed. Now, the outer guide K and outer handle A can besafely removed. The tract through the liver parenchyma is then balloondilated until the 10 French sheath can be successfully advanced from thehepatic vein through the liver parenchyma into the portal vein. Once thesheath is advanced into the portal vein, the TIPS stent is deployed perthe manufacturer's IFU and the diameter adjusted with balloonangioplasty until the desired portosystemic gradient is obtained.

The instant invention has been shown and described herein in what isconsidered to be the most practical and preferred embodiment. It isrecognized, however, that departures may be made there from within thescope of the invention and that obvious modifications will occur to aperson skilled in the art.

What is claimed is:
 1. A device used for establishing a transjugularintrahepatic portosystemic shunt quickly by locating a portal vein in aliver for receiving the shunt comprising: an elongated hollow outerguide; an outer handle having an inner lumen and a first luer lock, theouter handle attached at a proximal end of the outer guide, the outerguide in flow communication with the inner lumen and the first luerlock; an elongated hollow inner needle; a hub having a second luer lock,the hub attached at a proximal end of the inner needle, the inner needlein flow communication with the second luer lock; wherein the innerneedle is slidingly received through the first luer lock and into theouter guide through the inner lumen; wherein the inner needle isconfigured to rotate within the outer guide by manipulation of the hub;and wherein a distal tip of the inner needle is deployed out of andbeyond a distal tip of the outer guide, the distal tip of the innerneedle configured to be advanced into the parenchyma of the liver tolocate the portal vein.
 2. The device of claim 1, wherein the innerneedle is capable of aspiring fluid therethrough.
 3. The device of claim1, further comprising a hub cap removably received on the hub.
 4. Thedevice of claim 1, further comprising finger winglets on the outerhandle to assist in deployment of the inner needle.
 5. The device ofclaim 1, further comprising a marker on the hub providing an indicationof the orientation of the inner needle.
 6. The device of claim 1,wherein the distal tips of the outer guide and the inner needle havematching curved geometry;
 6. A method for quickly locating a liverportal vein necessary for performing a transjugular intrahepaticportosystemic shunt procedure comprising: providing a device comprisingan elongated hollow outer guide having an outer handle at its proximalend, the outer guide slidingly receiving an inner needle, the innerneedle having a hub at its proximal end, the inner needle configured torotate within the outer guide; catheterizing, through the jugular vein,a liver hepatic vein of a patient receiving the transjugularintrahepatic portosystemic shunt; inserting the device into the jugularvein and through to the liver hepatic vein; rotating the outer handle ofthe device until the outer guide is in the expected direction of theliver portal vein; stabilizing the outer handle and rotating the innerneedle by way of the hub in the expected direction of the liver portalvein; applying pressure to the hub and advancing the distal tip of theinner needle into the parenchyma of the liver, through the wall of theof the hepatic vein in a direction towards the portal vein; creating anaspirating force inside the inner needle to locate the liver portalvein; and establishing a shunt to the portal vein.